BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 10156227 · Received June 15, 2020

    Report

    Report Number
    2029214-2020-00560
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 10, 2020
    Report Date
    September 24, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536016385
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PIPELINE FLEX BRAID (MODEL: PED-450-14 LOT: A993673) RETURNED FOR ANALYSIS WITHIN SHIPPING BOX; AND WITHIN A PLASTIC BIO-POUCH. THERE WAS NO PUSHWIRE RETURNED WITH THE PIPELINE FLEX BRAID. WHEN COMPARED TO THE DRAWING. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID APPEARED TO BE FULLY OPENED AND SLIGHTLY FRAYED. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AS THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID WERE FOUND FULLY OPENED. IT IS LIKELY THAT THE SEVERE VESSEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE REPORTED ISSUE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE FAILED TO OPEN AT THE DISTAL SEGMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY WITH A MAX D IAMETER OF 7MM AND A 3MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE DISTAL SEGMENT OF THE PIPELINE FAILED TO OPEN. THE DEVICE WAS NOT IN A BEND, LESS THAN 50% WAS DEPLOYED, RE-SHEATHING WAS DONE LESS THAN THREE TIMES, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE PIPELINE. THE DEVICE WAS REMOVED FROM THE PATIENT. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS WERE GOOD. ANCILLARY DEVICES INCLUDE A NEURON MAXX, XT 27 MICROCATHETER, TRAXXS GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616146 PIPELINE FLEX LASER THERAPY PRODUCT OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-450-14 A993673 00847536016385

    Patients

    Seq Age Sex Outcome Treatment
    1